Companion Diagnostics In Oncologic Development: Idhifa And Lynparza Show Benefit Of Early Focus
Pink Sheet's Drug Review Profile looks at how Celgene's Idhifa sped from IND to approval, helped by prospective integration of a companion IDH2 mutation diagnostic into the clinical trial, while AstraZeneca's Lynparza was delayed by FDA concerns over retrospective analysis using germline BRCA mutation diagnostic.
You may also be interested in...
US FDA’s Information First Policy: PD-1 Bladder Cancer Alert Aligns With Complementary Diagnostics Perspective
Tecentriq and Keytruda's apparently lower efficacy in low PD-1/L1 patients in ongoing first-line trials prompts communication instead of restriction, underscoring FDA's emerging approach to precision medicine labeling.
Keeping Track: 2021’s First Novel Approvals Go To HIV And Heart Failure Therapies Opdivo Starts Year With A Bang
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Even in the grip of the pandemic, review times for priority drugs were also consistent with the last three years.